Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-29 @ 1:24 AM
Study NCT ID:
NCT06299293
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2024-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facial Emotion Recognition in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D000342', 'term': 'Affective Symptoms'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioural measure relative to recognition ability', 'timeFrame': 'baseline', 'description': 'Level of accuracy expressed in percentage (min =%; max = 100%) about only the valid trails, in the case of emotion used as target.'}], 'secondaryOutcomes': [{'measure': 'Behavioural measure relative to the detection ability', 'timeFrame': 'baseline', 'description': 'Reaction time (i.e., time of response from the onset of the visual stimulus) expressed in milliseconds relative to the valid response for the targeted emotion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Facial emotion recognition', 'Fear', 'Anger', 'Redundant target effect', 'Alexithymia'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'Altered emotional processing is reported in Anorexia Nervosa. However, this capability is generally measured through explicit measures, like self-report questionnaires and facial emotion recognition tasks. Instead, no previous research has investigated implicit emotional processing in this clinical condition. In the implicit facial emotion recognition task grounded on the implicit "redundant target effect", individuals generally respond faster when two identical targets are presented simultaneously rather than when presented alone; moreover, the competitive presence of a distractor (that is another emotion or a neutral expression) affects the correct recognition of the target. The ability to recognize and detect facial expressions is explored about two main emotions, fear and anger, because of their role in the intra- and interindividual psychological processing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with anorexia nervosa will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* right-handed\n* diagnosis of Anorexia Nervosa according to the APA criteria\n\nExclusion criteria:\n\n\\- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT06299293', 'acronym': 'FER_AN', 'briefTitle': 'Facial Emotion Recognition in Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Facial Emotion Recognition in Anorexia Nervosa', 'orgStudyIdInfo': {'id': '21C306'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Participants with Anorexia Nervosa', 'interventionNames': ['Other: Facial Emotion Recognition Test']}, {'label': 'Controls', 'description': 'Participants with a healthy weight', 'interventionNames': ['Other: Facial Emotion Recognition Test']}], 'interventions': [{'name': 'Facial Emotion Recognition Test', 'type': 'OTHER', 'description': 'In this test, the ability to detect and recognize facial expressions of fear or anger will be investigated.', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28824', 'city': 'Piancavallo', 'state': 'VCO', 'country': 'Italy', 'facility': 'IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe', 'geoPoint': {'lat': 46.00932, 'lon': 8.62916}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}